The present invention relates to a human large intestine flushing apparatus such as required for patients with large intestinal disorders including fecal incontinency or intractable constipation. More particularly, to an apparatus for automatic instillation of flushing fluids to the large intestine for managing bowel movements in patients exhibiting fecal incontinency, intractable constipation or related disorders who have undergone a Malone type, Monti plasty or similar surgical procedure wherein a catheterizable stoma is constructed into the large intestine allowing insertion of the instillation apparatus for the purpose of administering an Antegrade Colonic or Continent Enema (ACE).
Medical disorders of the large intestine can result in symptoms which prevent the patient from adequately evacuating fecal material from the large intestine. Fecally incontinent and intractably constipated patients have difficulties managing their bowel movement. Bowel movement management is typically accomplished by a daily flushing of the large intestine by enema wherein fluids are introduced into the large intestine to flush materials retained in the intestine. Fluids can be introduced from the rectum into the large intestine to flush and allowed to drain out. There are disadvantages with the application of a rectal enema flush including the lack of penetration of fluid throughout the entire interior of the large intestine, thereby leaving fecal matter lodged in the intestine, cleanliness issues, general difficulty of self application, lack of privacy, discomfort, and bulky enema equipment.
Surgical techniques have been developed to permit the application of an enema into the large intestine from the top of the intestine as opposed to the rectum. The enema from above or Antigrade Colonic Enema requires that a patient undergo a surgical procedure to create a stoma or entry through the skin into the intestine proximal to the top of the large intestine, principally to the cecum. Fluids are introduced and permitted to flush and drain to and out the rectum. Several surgical procedures have been developed to construct an entry point intestinal stoma proximal to the cecum. The Malone or Continent Appendicostomy surgical procedure constructs a connection conduit made between the appendix and the navel (belly-button) wherein a “button” or piercing is created at the navel. Using the “button” the patient can insert a needle or catheter and deliver fluid, a process known as instillation, into the large intestine as an alternative to performing a rectal enema. The procedure permits use of the appendix or neoappendix to be used as a way to administer an antegrade colonic enema or an antegrade continent enema without a rectal maneuver.
Another similar procedure known as a Monti plasty procedure surgically fashions a conduit between the large intestine and an insertion stoma in the skin also for purposes of instillation of an antegrade colonic enema.
Regardless of the technique elected to create a stoma entry into the large intestine, the instillation of fluids requires an external mechanism to introduce the fluids into the stoma and therefore into the intestine. Fluid is typically introduced to sweep the large intestine of fecal matter at least once a day.
Prior to the present invention, patients who have undergone a Malone, Monti or similar surgical procedure have been required to introduce fluids into the large intestine by means of a drip consisting typically of a saline filled bag elevated above the patient with a drain tube attached at one end to the bag and terminated by a needle or catheter at the other end which, in turn, is inserted into the button or piercing at the navel. Fluid is permitted to drip into the large intestine which migrates to the rectum and the flushing is accomplished. The drip procedure requires the patient to remain immobile and sitting on a commode as the fluid passes through the intestine and out the rectum for a period of several hours. The procedure typically requires on standard drip bag to be used.
More recently, flushing of the intestine through the entry stoma piercing has been accomplished by introducing fluids into the large intestine by utilizing a series of fluid-filled syringes. A large syringe filled with the flushing fluid is attached to a needle or catheter and inserted into the piercing or button. The fluid contents of the syringe is dispensed and then refilled periodically until the required amount of fluid is delivered. The syringe technique requires two competent people to administer. One caretaker is required to fill the syringe. At the same time the patient is responsible for pinching the catheter shut when the syringe is removed from the catheter as introduction of flushing fluid into the intestine produces back pressure. The catheter must be pinched shut to prevent fecal matter and intestinal fluid from flowing back through the catheter and out the now open catheter end when the syringe is removed for filling. The procedure using the syringe technique requires the syringe to be refilled 10 to 20 times. If the client is not competent or able enough to assist, a second caretaker is needed. Many individuals requiring this type of treatment often have other handicaps that prevent them from assisting themselves. The use of multiple syringes also increases the risk of introducing air into the installation fluid. The introduction of air into the stoma necessarily induces significant discomfort or pain in the patient.
Automated instillation devices directed to address the disadvantages of the drip bag and syringe techniques exhibit the principle disadvantage associated with the difficulty to manipulate the various elements of the device as required during self-administration, usually requiring the use of both hands for manipulation. Devices with separate fluid reservoir bags must be separated from the apparatus in preparation to fill the reservoir bag a manuvour that requires dexterity not always present in patients requiring the apparatus. Further, separation of the fluid reservoir can introduce air into the pump potentially causing discomfort to the patient during the administering the procedure.
In order to determine when a predetermined volume of instillation flushing fluid has been delivered, a pump control system may monitor the pump motor current and stop the pump motor with the pump motor current draw increase as a sealed collapsible fluid reservoir is depleted of fluid. The disadvantage of this technique is that current draw from the pump varies between pumps, the viscosity of flushing fluid, and the varying fluid resistance resulting from using differing sizes of catheters, thereby resulting in difficulties starting the apparatus and causing the pump to run dry.
There is a need for an improved instillation apparatus and method to administer an antegrade colonic that avoids these disadvantages. The present invention fulfills this need, and further provides related advantages.